Journal of Pharmacovigilance

Nimesulide benefit-risk assessment: How to keep under control the safety profile of a mature drug?

Conference Series LLC Joint International Event on 7^th Pharmacovigilance & Pharmaceutical Industry

August 22-24, 2016 Vienna, Austria

Mario Bertazzoli

Helsinn Healthcare SA, Switzerland

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

A continuous evaluation of the positive therapeutic effects of a medicinal product in relation to the risks is of paramount relevance also for a mature drug that has been on the market from many years. Regulatory authorities, may, at any time, ask the marketing authorization holder to forward data demonstrating that the benefit-risk balance remains favourable and it is continuously assessed. Nimesulide is a COX-2 preferential NSAID (Nonsteroidal anti-inflammatory drugs) characterized by a particularly rapid onset of analgesic action. The widespread nimesulide post-marketing use has contributed to better understanding of its favourable safety profile. However, the extensive use of a drug poses unique challenges, since; even a rare but severe risk can have a significant impact on the population. A safety referral under Article 31 (Directive 2001/83/EC) may be initiated in specific cases where the interest of the public health in the European Union is involved. For example, following concerns related to the benefit-risk balance of a medicinal product. The actions taken to keep the possible risk under control, regarded the conduction of non-interventional studies, education of prescribers on the correct use of the drug and risk minimization actions. The efficacy of these actions has been monitored through drug utilization studies that have shown how nimesulide is, in the vast majority of cases, prescribed according to the approved label.

Biography :

Mario Bertazzoli is a Physician and a Registered Specialist in Human Reproduction Pathology. He received both Medical and Specialization degrees from the University of Milan, Italy. He worked since 1995 for international pharmaceutical companies as Pharmacovigilance and Pharmaco-Epidemiology Physician. He is currently the Head of Corporate Drug Safety and Reference Physician to the EU Qualified Person for Pharmacovigilance for the Helsinn Group. He is Founder and Treasurer of the International Society of Pharmacovigilance, Swiss-Austrian Chapter.

Email: mario.bertazzoli@helsinn.com